A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AND/OR FOLLOWING CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED EPITHELIAL OVARIAN CANCER JAVELIN OVARIAN 100
A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AND/OR FOLLOWING CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED EPITHELIAL OVARIAN CANCER JAVELIN OVARIAN 100
This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy.
The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.
Key Inclusion Criteria:
Key Exclusion Criteria:
Los Angeles, California 90048, United States
Orange, California 92868, United States
San Francisco, California 94109, United States
San Francisco, California 94115, United States
San Francisco, California 94115, United States
New Haven, Connecticut 06510, United States
Baltimore, Maryland 21287, United States
Boston, Massachusetts 02114, United States
Springfield, Missouri 65804, United States
Columbus, Ohio 43210, United States
Columbus, Ohio 43212, United States
Pittsburgh, Pennsylvania 15232, United States
Szolnok, 5000, Hungary
Bologna, BO 40138, Italy
Bologna, BO 40138, Italy
Sondrio, SO 23100, Italy
Roma, 00168, Italy
Kashiwa-shi, Chiba 277-8567, Japan
Sakyo-ku, Kyoto 606-8507, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Chuo-ku, Tokyo 104-0045, Japan
Minato-ku, Tokyo 105-8471, Japan
Sittard-Geleen, 6162 AP, Netherlands
Sittard-Geleen, 6162 BG, Netherlands
Krakow, 31-115, Poland
Poznan, 60-535, Poland
Ivanovo, Ivanovo Oblast 153040, Russia
Obninsk, Kaluga Oblast 249036, Russia
Orenburg, Orenburg Oblast 460021, Russia
Kazan', Tatarstan Republic 420029, Russia
Moscow, 111123, Russia
Saint Petersburg, 197758, Russia
Seongnam-si, Gyeonggi-do 13496, South Korea
Kryviy Rig, 50048, Ukraine
Lviv, 79031, Ukraine
Uzhhorod, 88000, Ukraine
Bebington, Wirral, Merseyside CH63 4JY, United Kingdom
Metropolitan Borough of Wirral, Merseyside CH63 4JY, United Kingdom